On February 2, 2024 Delta-fly Pharma reported that it is excited to share its latest development status (Press release, Delta-Fly Pharma, FEB 2, 2024, View Source [SID1234639806]).

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As presented at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival (mPFS; 23.1 months).

Subsequently, based on these results, we have been in negotiation with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan with the aim of submitting a conditional approval application, resulting in our decision to conduct a Phase III clinical trial (superiority study) of DFP-14323 in combination with afatinib (20 mg/day) versus afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive based on the PMDA’s recommendation.

And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.

This Phase III clinical trial will be conducted at 30 sites in Japan and if the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint, is confirmed in this trial, we believe that DFP-14323 will be a novel cancer immunotherapy drug with highly beneficial for patients and their families, as it is orally available, safe, and economical.

Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.

We intend to continue negotiations for out-licensing opportunities with pharmaceutical companies for the territory outside Japan.

Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO:4598) and contact with us.

On February 1, 2024 General Proximity reported the company has been awarded a NIH NCI SBIR Phase I grant (Press release, General Proximity, FEB 1, 2024, View Source [SID1234649814]). This $400k grant will drive our efforts to develop groundbreaking treatments targeting Triple Negative Breast Cancer (TNBC), one of the most challenging and aggressive forms of breast cancer.

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This award represents a pivotal step forward in our mission to innovate and develop transformative treatments for patients facing critical unmet needs.

On February 1, 2024 Hoffmann-La Roche reported its full year and fourth quarter 2023 results (Press release, Hoffmann-La Roche, FEB 1, 2024, View Source [SID1234639965]).

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On February 1, 2024 ArteraAI, the developer of multimodal artificial intelligence (MMAI) based predictive and prognostic cancer tests, reported that it has secured an additional $20 million in capital fueled by several prominent large investment funds including Prosperity7 Ventures, Singapore-based global investor EDBI, Walden Catalyst Ventures, Wilson Sonsini Goodrich & Rosati, and Trium Ventures, along with investors Navin Chaddha, Rajiv Khemani (AISpace VC), and Andrew & Elliott Tan (A&E Investment LLC) (Press release, Artera, FEB 1, 2024, View Source [SID1234639808]).

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"The infusion of this additional funding is a crucial catalyst, propelling ArteraAI forward in its mission to personalize cancer therapy through AI-enabled predictive and prognostic tests," said Andre Esteva, CEO and Co-Founder of ArteraAI. "We are committed to ushering in the era of precision medicine, and stewarding this investment strategically to aid in our international expansion and commercial growth."

This funding announcement follows closely on the heels of ArteraAI’s recent achievement of the Centers for Medicare and Medicaid Services (CMS) decision on the payment rate for the ArteraAI Prostate Test. The decision helps to ensure broader accessibility to AI-enabled personalized care, benefiting a larger population.

"Investing in ArteraAI wasn’t just a financial decision, but a testament to ArteraAI which is globally revolutionizing patient care," said Abhishek Shukla at Prosperity7 Ventures. "We are thrilled to be part of the journey as ArteraAI continues its mission to provide patients with access to personalized cancer treatment plans."

Less than a year ago, ArteraAI emerged from stealth mode with an initial funding of $90M. Since then, the company has made significant strides, obtaining a Medicare payment rate, growing distribution and establishing a solid foundation for international expansion through strategic global partnerships to continue its research.

"ArteraAI’s AI-driven tests represent a transformative approach to designing tailored cancer care regimens. This offers a glimpse into the future where cancer care is truly personalized, aligning with Singapore’s efforts to digitize healthcare and harness AI to enable precision medicine," said Dr. Jolene Ooi, Senior Principal at EDBI. "We are excited to be part of their growth story and look forward to supporting its foray into Asia."

To learn more about ArteraAI visit Artera.ai.

On February 1, 2024 DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, reported availability of the company’s fragmentome-based research use only (RUO) cancer monitoring assay (Press release, Delfi Diagnostics, FEB 1, 2024, View Source [SID1234639805]). The DELFI-Tumor Fraction (DELFI-TF) assay is a highly sensitive, inexpensive means of noninvasive measurement of tumor burden and assessing treatment response and resistance in patients with advanced cancer.

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Additionally, DELFI announced a new research collaboration with Immunocore Holdings plc (Nasdaq: IMCR) – a commercial-stage biotechnology company pioneering the development of a novel class of bispecific T cell receptor (TCR) immunotherapies against cancer (ImmTAC molecules) – focused on exploring the use of the DELFI-TF cancer monitoring assay as an early predictor of benefit from treatment with ImmTAC-based therapies.

"The DELFI-TF assay delivers a genome-wide measure of the proportion of cfDNA derived from a tumor and it is highly correlated with the mutant allele fraction (MAF) that is often used to evaluate treatment response and resistance to immunotherapies in advanced cancer patients. Our fragmentome-based assay has numerous advantages as it requires very little plasma, has a low cost of processing, and is not confounded by clonal hematopoiesis or driver mutation switches," said Nicholas C. Dracopoli, Ph.D., co-founder and Chief Scientific Officer of DELFI. "We are excited that Immunocore will be further exploring the clinical and research potential of the DELFI liquid biopsy platform as a new approach to monitoring treatment response."

The DELFI-TF RUO assay is also being evaluated by additional parties across the pharmaceutical industry for its potential application in advancing other healthcare discoveries, and DELFI anticipates announcing more research collaborations in the near term.